Events

Retiro De Equipo (Recall) de Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00030-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00030-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The speakers in camino icp monitors (cam02) and the licox pto2 and temperature monitors (lcx02) may potentially malfunction. if this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; moderate hypoxic brain injury; elevation of icp or decrease in pto2. no reports of patient injury or adverse events have been received.
  • Acción
    The affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. The monitor case will also be modified to increase the decibel level.

Device

Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Mon...
  • Modelo / Serial
    Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) MonitorCatalogue Number: CAM02 All serial numbers affectedIntegra Licox PtO2 and Temperature MonitorCatalogue Number: LCX02All serial numbers affectedARTG Number: 216915 and 217355
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd